NEORAL®

25mg, 50mg, 100mg Capsules

100mg/ml Solution

Cyclosporin

What is in this leaflet

This leaflet answers some common questions about Neoral.

It does not contain all the available information. It does not take the
place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you taking Neoral against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Neoral is used for

Neoral is used for people who have had a kidney, heart, lung, pancreas or
liver transplant, to prevent the body from rejecting the new organ. Neoral is
also used in bone marrow transplantation

Neoral is also used to treat several other conditions which are thought to
be caused by a problem with the immune system:

• a kidney disease called nephrotic syndrome
• severe cases of rheumatoid arthritis
• severe cases of psoriasis and atopic dermatitis (skin diseases)
• endogenous uveitis

Neoral contains the active ingredient, cyclosporin. It belongs to a group
of medicines called immuno-suppressants. These medicines help to control your
body's immune system.

Ask your doctor if you have any questions about why this medicine has
been prescribed for you.

Your doctor may have prescribed it for another reason.

Neoral is only available with a doctor's prescription. It is not addictive.

Before you take Neoral

When you must not take it

Do not take Neoral if you have ever had an allergic reaction to
cyclosporin, the active ingredient in Neoral, or to any of the other
ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include hives or an itchy skin rash,
swelling of the face, lips or tongue, faintness, wheezing or troubled
breathing.

Do not take Neoral after the expiry date printed on the pack or if the
packaging is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Use in children

Experience with Neoral in children is still limited. However, children from
1 year of age have received Neoral in standard dosage with no particular
problems. In several studies, pediatric patients required and tolerated higher
doses of Neoral per kg body weight than those used in adults.

Before you start to take it

If you have been prescribed Neoral for nephrotic syndrome, rheumatoid
arthritis, psoriasis or atopic dermatitis, tell your doctor if you also have
any of these health problems/medical conditions:

• high blood pressure that is not controlled
• any uncontrolled infection
• a poorly functioning immune system
• problems with your kidneys or liver
• severe heart, lung or blood vessel disease
• any type of cancer, including skin cancer

Your doctor may not want you to take Neoral or may want to take special
precautions if you have any of these conditions.

Tell your doctor if you are pregnant or intend to become pregnant.

Experience with Neoral in pregnancy is very limited. The use of
immunosuppressant medicines, including cyclosporin, during pregnancy has been
shown to increase the risk of problems in the mother and the unborn child. If
it is necessary for you to take this medicine, your doctor will discuss with
you the benefits and risks of taking it during pregnancy.

Tell your doctor if you are breast-feeding.

Breast-feeding is not recommended since cyclosporin, the active ingredient in
Neoral, passes into breast milk and may affect your baby.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any
that you buy without a prescription from a pharmacy, supermarket or health
food shop.

Many other medicines may be affected by Neoral or they may affect how well
Neoral works. This includes:

• a wide range of prescription medicines (please refer to full prescribing
  information)
• St John's wort, an ingredient in many medicines that you can buy without
  a prescription from a pharmacy, health food shop or supermarket.

You may need to take different amounts of your medicines or you may need to
take different medicines.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking Neoral.

If you have not told your doctor about any of these things, tell him/her
before you take Neoral.

How to take Neoral

Follow all directions given to you by your doctor and pharmacist
carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor
or pharmacist for help.

If you are changing from Sandimmun to Neoral

Some patients who have been prescribed Neoral would have taken Sandimmun in
the past. Like Neoral, Sandimmun contains the medicine, cyclosporin. Neoral,
however, is designed to improve the way cyclosporin gets into your
bloodstream. Because of this, your dose of Neoral may eventually be less than
the dose of Sandimmun you used to take. If you are changing from Sandimmun to
Neoral, your doctor will perform some extra blood tests and then decide
whether to change your dose of Neoral.

Do not change from Neoral to Sandimmun or from Sandimmun to Neoral
unless it is under the strict supervision of your doctor.

Do not take Neoral and Sandimmun at the same time.

How much to take

The dose of Neoral is worked out for each person. It will depend on how
much you weigh, what condition is being treated, how well Neoral works for
you, and whether you have any side effects from this medicine. Your dose may
be changed from time to time.

How to take it

Capsules:

• Do not remove the capsules from the foil blister pack until you are
  ready to take them.
• Swallow the capsules whole with a full glass of water.
• Do not chew them.

Oral solution:

• Measure out the dose using the syringe provided.
• Add the dose to a glass of orange juice, apple juice or soft drink just
  before you take it. Do not use grapefruit juice.
• Make sure the syringe does not touch the liquid in the glass.
• Stir the liquid well immediately before drinking it.
• Rinse the container with more juice or soft drink to make sure that the
  whole dose has been taken.
• Wipe the outside of the syringe with a clean, dry tissue and put it back
  into its case. Do not wash the syringe with water, alcohol or any other
  liquid.

For full details on how to take Neoral oral solution, read the separate
leaflet contained in the carton.

When to take it

Always take Neoral twice a day. It is best to take the doses 12 hours
apart if possible. Take them at about the same time each day.

Taking your doses 12 hours apart and at the same time each day will have the
best effect. It will also help you remember when to take them.

How long to take it

Keep taking this medicine for as long as your doctor recommends.

The length of treatment will depend on what medical condition you have.

For transplant patients: you will need to take one or more
immunosuppressant medicines for as long as you have the transplanted organ.

For nephrotic syndrome: you may take Neoral for 3 months to start
with. If it helps your condition, your doctor may decide to continue Neoral
treatment for as long as it helps you and does not cause serious side effects.

For severe rheumatoid arthritis: you will usually take Neoral for 3
months to start with. It may take this long to know whether Neoral will help
your condition. If Neoral is effective, your doctor may then lower the dose
and you will continue treatment at the lowest dose that is suitable for you.

For severe psoriasis: you will usually take Neoral for up to 6 weeks
to start with. If your condition improves, your doctor may want you to
continue treatment at the lowest effective dose. You can only expect to
benefit from this medicine while you continue to take it.

For severe atopic dermatitis: you will usually take Neoral for up to
8 weeks to start with. Once your condition has improved, the dose may be
slowly reduced, and in some cases, may even be stopped. Once you have stopped
taking Neoral, your condition is likely to return, although this may take
several weeks or months. Your doctor may then want you to start taking Neoral
again.

For endogenous uveitis: you will usually take Neoral until remission
is achieved. If Neoral is effective, your doctor may then lower the dose and
you will continue treatment at the lowest dose that is suitable for you.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and
take the next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking
it as you would normally.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you miss more than one dose, contact your doctor as soon as possible.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or the National Poisons Information
Centre, Dunedin (telephone number 0800 POISON or 0800 764 766), or go to the
Accident and Emergency Department at your nearest hospital if you think that
you or anyone else may have taken too much Neoral. Do this even if there are
no signs of discomfort or poisoning.

Keep the telephone numbers for these places handy.

While you are taking Neoral

Things you must do

Take Neoral exactly as your doctor has prescribed.

You must take this medicine exactly as prescribed so that it will work
properly and to prevent unwanted side effects.

Make sure that you keep all of your doctor's appointments and have any
tests done that are ordered by your doctor.

Your doctor may ask you to have tests from time to time to check how well your
kidneys and liver are working. It may be necessary to measure the amount of
cyclosporin, as well as the levels of other chemicals (eg. potassium) in your
blood. Your blood pressure will also be checked regularly.

Avoid eating large amounts of foods that are high in potassium.

In some people taking Neoral, the amount of potassium in the blood can
increase (called hyperkalaemia). The amount of potassium in the blood can also
be increased by eating certain foods. Your doctor can tell you which foods to
avoid.

If you become pregnant while taking Neoral, tell your doctor.

Your doctor can discuss with you the risks of taking it while you are
pregnant.

If you develop lumps anywhere in your body, or develop any moles, or you
notice changes in existing moles, tell your doctor.

This may be an early sign of a cancer. Immunosuppressant medicines, including
Neoral, may increase the risk of developing certain cancers, including skin
cancer and lymphoma (cancer of the lymphatic system).

If you go out in the sun, wear a hat, protective clothing and sunscreen.


This will help to prevent the development of skin cancer.

If you have psoriasis or atopic dermatitis, you must be especially
careful about developing skin cancer. Visit your skin specialist regularly for
check-ups.

Take special care of your teeth and gums.

People taking immunosuppressant medicines are at a greater risk of getting
infections. Taking good care of your teeth and gums will help to prevent
dental and mouth infections.

If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are taking Neoral.

Tell any other doctor, dentist or pharmacist who treats you that you are
taking Neoral.

Things you must not do

Do not have any vaccinations without first checking with your doctor.

Some vaccines may be less effective or they may cause unwanted side effects
while you are taking Neoral.

Do not give this medicine to anyone else even if their condition seems
similar to yours.

Do not take it to treat any other complaints unless your doctor tells
you to.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you
to be alert while you are taking Neoral until you know how it affects you.

This medicine can cause tiredness, lack of energy or confusion in some people.
If you have any of these symptoms, do not drive or do anything else that could
be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking Neoral, even if you do not think it is connected
with the medicine.

All medicines can have side effects. Sometimes they are serious, but most of
the time they are not. You may need medical treatment if you get some of the
side effects. Your doctor may be able to relieve some of the side effects of
Neoral by lowering the dose.

If you are over 65 years old, you should be especially careful while
taking this medicine. Report any side effects promptly to your doctor.

As people grow older, they are more likely to get side effects from medicines.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• tiredness, lack of energy
• burning feeling in hands and feet, usually during the first week of
  treatment
• excessive growth of body and facial hair
• thickened, swollen or bleeding gums
• stomach upset, including nausea (feeling sick), vomiting, loss of
  appetite, diarrhoea, stomach cramps
• tremor (shaking)
• headache
• weight loss or gain
• feeling depressed (sad)
• flushing of face, acne, darkening of skin
• painful menstrual periods or lack of periods
• increase in size of breasts in males
• muscle cramps, tenderness or weakness
• blocked or stuffy nose

The above side effects are not usually serious.

Tell your doctor immediately if you notice any of the following:

• fever (temperature above 37°C)
• constant "flu-like" symptoms such as chills, sore throat, aching joints,
  swollen glands, or any other signs of infection
• unusual bleeding or bruising
• signs of allergy such as rash, itching or hives on the skin; swelling of
  the face, lips, tongue or other part of the body; shortness of breath,
  wheezing or troubled breathing
• new lumps or moles, or changes to existing moles, anywhere on the body
• swelling of the eyelids, hands or feet due to excess fluid
• a change in the amount of urine passed or in the number of times you
  urinate, pain on urinating, bloody or smelly urine
• yellowing of the skin and/or eyes (jaundice) often accompanied by
  generally feeling unwell (for example, tiredness, lack of energy, loss of
  appetite, nausea and vomiting, pain in the abdomen)
• severe pain or tenderness in the stomach or abdomen
• vomiting blood or material that looks like coffee grounds; black sticky
  bowel motions or bloody diarrhoea
• unusual tiredness or weakness, which may be accompanied by dizziness,
  spots before the eyes, shortness of breath and pale skin
• numbness or "pins and needles" in the hands and feet
• a disturbance in brain function which may cause a variety of symptoms,
  including confusion, disorientation, agitation, inability to sleep,
  decreased responsiveness, weakness and incoordination in arms and legs,
  seizures (fits), visual hallucinations (seeing things that are not there) or
  other problems with vision
• buzzing or ringing in the ears, difficulty hearing

The above are serious side effects that need medical attention.

Some side effects may not give you any symptoms and can only be found
when tests are done. Some of these side effects include:

• changes in kidney or liver function
• raised blood pressure
• an increase in the amount of potassium or cholesterol in the blood
• a decrease in the amount of magnesium in the blood
• an increase in the amount of uric acid in the blood, which can lead to
  gout
• an increase in blood sugar

Your doctor will make sure that tests are done regularly to watch for these
side effects.

Tell your doctor if you notice anything else that is making you feel
unwell.

Other side effects not listed here may happen in some people.

After using Neoral

Storage

Capsules:

• Keep your capsules in the foil blister pack until it is time to take
  them. If you take the capsules out of the blister pack, they will not keep
  well.
• Store the pack in a cool dry place where the temperature stays below
  25°C.

Oral solution:

• Do not keep the bottle of oral solution in the fridge. Store it in a
  cool dry place, where the temperature stays between 15°C and 30°C, but
  preferably not below 20°C. At low temperatures, the solution may start to go
  cloudy, or even start to set like a jelly. It will turn back to a liquid
  when kept at a warmer temperature. There may still be some small flakes in
  the liquid after it warms up. These flakes will not affect how Neoral works.
• Once the bottle has been opened, use the solution within 2 months. After
  that time, dispose of any solution that is left over.

Keep the medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.

Disposal

If your doctor tells you to stop taking Neoral or it has passed its
expiry date, ask your pharmacist what to do with any medicine you have left
over.

Product description

What it looks like

Neoral 25 mg capsules: blue-grey, oval, soft gelatin capsules, printed in
red with the NVR and "25 mg;" in foil blister packs of 50.

Neoral 50 mg capsules: yellow-white, oblong, soft gelatin capsules, printed
in red with the NVR and "50 mg;" in foil blister packs of 50.

Neoral 100 mg capsules: blue-grey, oblong, soft gelatin capsules, printed
in red with the NVR and "100 mg;" in foil blister packs of 50.

Neoral oral solution: clear, faintly yellow-brownish liquid in a 50 mL
glass bottle, with a syringe for measuring the dose.

Ingredients

Neoral capsules contain 25 mg, 50 mg or 100 mg of the active ingredient,
cyclosporin. Neoral oral solution contains 100 mg cyclosporin in each mL of
solution.

The capsules and solution also contain:

• dl-α-tocopherol
• ethanol (alcohol)
• propylene glycol
• corn glycerides
• polyoxyl 40 hydrogenated castor oil
• macrogolglycerol hydroxystearate

Neoral capsule shells contain:

• gelatin
• propylene glycol
• glycerol
• titanium dioxide
• iron oxide black CI 77499 (25 mg & 100 mg capsule shells only)

The printing ink on the capsules contains:

• carminic acid CI 75470
• aluminium chloride
• sodium hydroxide
• hydroxypropyl methylcellulose 2910